The American Public Health Association (APHA) has repeatedly endorsed the precautionary principle as a cornerstone of preventive public health policy and practice, both in the United States and throughout the world.4–6,8,9 Recognizing immunization as a premier public health intervention of the 20th century, APHA has advocated for effective implementation of universal immunization2,5,7 and recommended requiring all health and laboratory workers, as well as students in these fields, to be immunized against all vaccine-preventable diseases.7 This position statement examines influenza prevention in the United States today in the context of this longstanding APHA position. Immunizing health workers against influenza has an impact on the workers themselves and their coworkers and families, on patients in the healthcare facilities and community-based settings where they work, on overall communitywide immunity, and on the health system’s capacity to provide safe care and its readiness to meet both routine and emergent service demands.

The Problem

Influenza and its complications account for the greatest number of vaccine-preventable deaths worldwide: one-quarter to one-half million deaths occur every year from approximately 3 to 5 million infections that cause severe disease and hospitalization10–12 The actual number of symptomatic cases is much higher, with the greatest burden falling on the least privileged in countries without access to the same level of preventive and medical care that is available in developed countries, such as the United States.13 The World Health Organization’s (WHO’s) Strategic Advisory Group on Immunization puts control of seasonal influenza into the same priority as cholera, typhoid, and yellow fever.14

In the United States, influenza annually affects approximately 15% of adults; 15 to 60 million cases lead to 250,000 or more hospitalizations and from 20,000 to more than 40,000 deaths.15–23 Influenza-related death toll estimates in some years have reached as high as 80,000. Together with pneumonia, it is the 8th leading cause of death in the United States and the 5th leading cause of death among those 65 years old and older24—with annual direct medical costs of $3 billion to $10.4 billion and $16.3 billion in indirect costs.25–30 Local epidemics are frequent.

As its population ages, the United States has been experiencing higher influenza-related mortality, including influenza pneumonia and cardiopulmonary disease. Although not more susceptible to infection, people older than 65 years are typically at highest risk for complications and death from the disease. From 1979 to 2000, influenza hospitalization rates for elderly patients were 17 times higher than the average rate, and more than 90% of the patients who died were elderly.31–33 Yet more than half of influenza-related hospitalizations are reported in people younger than 65 years.20,32 Estimated rates of influenza-associated hospitalization and death start to rise around 50 years of age and continue upward thereafter.24,32,33

Pregnant women experience more complications than others with influenza. Besides being less likely to become infected with influenza during infancy, the newborns of women who had influenza vaccine when pregnant weigh more and are healthier at birth than those whose mothers did not.34,35

Influenza can trigger the complications of chronic disorders. People with diabetes; cardiovascular disease; or chronic lung, renal, or liver conditions are at higher risk for influenza morbidity and complications.36–51 During periods of high influenza incidence, hospitalizations of adults with these high-risk medical conditions may increase 2- to 5-fold, depending on age group. People with cancer and other immunocompromising conditions are especially susceptible to severe complications.45,46,47 Influenza-related hospitalization rates in adults younger than 65 years with cancer are 5 to 10 times higher than for the general population and 3 to 5 times higher in people with cancer older than 65 years—higher than for other high-risk groups.45,48 With an estimated 7% to 10% death rate, cancer patients are 10 times more likely to die than others hospitalized with flu-related infections, and this mortality impact is particularly notable among those younger than 65 years.45 Residents in long-term care facilities have a greater risk for infection because they live in close quarters in closed settings and have contact with numerous caregivers. Because residents often have multiple underlying medical problems, long-term care facility outbreaks are associated with significant morbidity and mortality.20,52–55

Protecting Health Workers From Influenza

Health workers include all workers who, during the course of their work, have direct or indirect contact with the recipients of a preventive or restorative health service or related social or counseling services or with their caregivers, family members, or household members—regardless of the location where they perform their work. This contact may be a part of their normal work duties or may occur incidental to work activities—routinely or infrequently. They include full-time and part-time employees, contract or per diem workers, independent consultants, volunteers, trainees, and students. Those not directly involved in direct care may, nevertheless, be exposed to infected people; infectious materials; or contaminated supplies, equipment, or environmental surfaces (e.g., food and housekeeping service workers).

Community health workers (also called health advisors, health representatives, liaisons, promotores de salud, and related titles) work in diverse, informal, community-based settings (such as homes, schools, churches), often in unpaid capacities for health or social service agencies or other community organizations serving high-disparity populations. They provide the frontline links to health promotion and maintenance for many of the most vulnerable and needy populations. Their activities include, but are not limited to, outreach, informal counseling, social support, advocacy, and education of both clients and staff to facilitate access to culturally competent service delivery.

APHA advocates protecting US workers on the job as a top priority for the president and Congress. This agenda includes putting worker health and safety first, ensuring protection through tough enforcement of existing regulations, establishing new worker protections, and increasing worker participation in workplace safety and health programs.55 With more than 12 million workers, health care is the second fastest growing sector of the US economy.56 More than 13% of US workers have jobs in the healthcare sector, according to the US Department of Labor.57 Any workplace can be a setting for influenza transmission (not just healthcare facilities). Health workers can likewise be exposed to influenza anywhere in the community. Occupational exposure to infected patients, however, especially those with unrecognized infection, heightens risk for health workers. If infected at work, they can, in turn, unknowingly transmit infection to coworkers and carry infection home to family members.

Up to 25% of unvaccinated health workers may be infected each year.40,58,59 Health workers themselves (and their family members) frequently have medical conditions that raise their risk for influenza morbidity and mortality.60 In addition, the frequently noted aging of the healthcare workforce places an increasingly greater number and proportion of health workers in a higher-risk category.

Influenza infection is readily spread by respiratory droplets. It mainly spreads from person to person when a host coughs or sneezes, with greater contagion in semiclosed or crowded environments. Less efficient transmission also may occur through indirect contact, such as touching something already laden with virus, then touching the eyes or nose. Symptoms usually appear 1 to 4 days after infection, and an infected person is contagious during this asymptomatic period. Approximately 20% of cases remain subclinical.11,20 Thus, we cannot rely on signs of another person’s illness to alert us to use protective barriers, nor is an infected person necessarily even aware of having been exposed.

Annual vaccination is the most effective method for preventing influenza infection and its severe complications.21,22,61–69 Primary prevention by vaccination is therefore at the top of the influenza infection control hierarchy. Influenza vaccination of healthcare workers is the single most important measure for preventing occupation-acquired and nosocomial influenza from both known and unexpected sources. Other measures, such as hand hygiene and barrier precautions, are additional protective steps, not alternatives. Masks or respirators, whether worn by people with influenza-like illness (ILI) symptoms or those who are in proximity to them, are not as protective as preexposure immunization, especially given the high proportion of asymptomatic infectious people. Influenza occurs in healthcare workers even when there is high personal protective equipment (PPE) adherence.59 Improving influenza vaccination rates in health workers is thus essential for their safety and for infection control.

Social Justice Perspective—For Workers and Patients

Addressing the risk to patients is an especially salient social justice issue when poverty, poor health infrastructure, low health literacy, or lack of information influence their susceptibility status.70–72 In turn, unvaccinated people can experience a double jeopardy disparity when, in a healthcare setting, they are exposed to infected personnel—the healthcare system fails them twice.

Unvaccinated status may reflect a disparity in access to the primary care that should afford a person timely counsel from a healthcare provider to get vaccinated.73 Access to health care is a predictor of influenza vaccination, even among those at high risk for complications.43,71,74 Access limitations exist not only for people in medically underserved or low socioeconomic communities, but also for many others who, for whatever reason, lack a medical home or may not know that gratis vaccination is available or where to find it. A high proportion of health workers represent minority ethnic groups, including many immigrants, and health workers from different racial and ethnic groups have significantly different immunization vaccination rates.38,39,43,44,73–75

Chronic conditions that put people at higher risk for influenza-related morbidity and mortality, such as diabetes and asthma, are more prevalent in African Americans and Hispanics than in Whites. Yet influenza vaccination rates are lower in these populations, including among those with greater influenza risks, such as the elderly and people with diabetes or heart, lung, or renal disease.38,39,43,44,48–50,71,73–77 African Americans have a higher influenza hospitalization rate than other races/ethnicities.

The strongest and most frequently asserted ethical principle is that the healthcare provider’s primary duty is to protect and avoid harming those served, often articulated as “First, do no harm.” The healthcare consumer has the right to assume that health workers, and the organizations that employ them, will take all reasonable measures to avoid transmitting communicable pathogens for which safe and effective vaccines exist.78–81 Bioethicist Arthur Caplan maintains, “Getting a flu shot is the least those who claim to be bound by professional ethics ought to do.”82 American Nurses Association President Rebecca Patton enjoins her colleagues, “As nurses, we have an ethical obligation to protect ourselves, our patients, and our families from illness. Vaccination is one simple step we can take to do that.”83 Matthew Wynia, Director of the American Medical Association Institute for Bioethics, adds that “patients should be informed when they are seeing a healthcare worker who has refused vaccination.”81

The public reporting of staff vaccination rates at healthcare facilities as both a quality measure and a matter of transparency to inform communities, patients, and visitors has also been recommended21,40,78,81 as a component of retrospective patient safety “report cards” with real-time, facilitywide, and unit-specific posting during influenza seasons. Current Medicare-Medicaid requirements for reporting of nursing home residents’ vaccination rates could be expanded to include staff coverage too.

Improving Vaccination Coverage of Health Workers

Improving influenza vaccination rates in health workers provides benefits to workers, patients, and health service agencies. Preventing both community and workplace influenza transmission to health workers is essential both for maintaining a safe work environment in healthcare settings and for ensuring staffing capacity. ILI-related absenteeism can cause or exacerbate significant staffing shortages, which can be especially problematic during influenza’s peak periods.28,29,59,60,84–86 Staff immunization is highly cost-effective and can be cost saving.25,26 Additional costs for healthcare organizations implicit during and after a nosocomial influenza outbreak are also relevant considerations.26,28,29

Since 1984, the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has continually recommended universal annual influenza vaccination for health workers.87 At the millennium, 60% was targeted as the national 2010 health objective for healthcare personnel and all adults younger than 64 years, with a 90% goal for older adults.77 Other professional groups have consistently supported and endorsed these recommendations and proposed ways for institutions to improve their personnel vaccination rates. A 2004 National Foundation of Infectious Diseases initiative called on healthcare institutions to ensure influenza vaccination is available and offered to every health worker every year.65 Since 2007, the Joint Commission has required accredited hospitals and long-term care facilities to offer influenza vaccination to staff and independent licensed practitioners as a patient safety and infection control standard.88,89 Unions, too, urge strong enforcement of prevention steps to protect health workers, including influenza vaccination,56,90,91 encouraging members working in health services to get influenza vaccination and calling for healthcare employers to provide free vaccination to employees.91 Nevertheless, the vaccination rate among health workers has remained dismally low, typically less than 30% (often much lower) and infrequently reaching 50%, even in hospital units caring for high-risk patients.92 By the 2008–2009 season, few institutions reported rates as high as 50%, even those with aggressive programs to promote staff vaccination.92–96 In fact, as a group, health workers are among the most poorly covered.68 By mid-January 2010, after unprecedented intense, communitywide promotion efforts across the country, the highest level ever was reached, though it was still less than 70%.97

Barriers to workers’ accepting getting vaccinated against influenza can be financial, structural, and attitudinal1.47,63–65,84,91,93,94,98–116 Best practices from effective promotional campaigns by hospital employers have been identified.65,83,88,89,95,118 However, even with incentives and vigorously implemented, intensive promotional campaigns that use a panoply of these strategies, vaccination rates can remain significantly below 50%; very few hospitals report achieving rates of 80% or more.65,84,929,118,119 A ceiling effect—below desired levels for group protection (herd immunity)—has been inferred.119 Reports of substantial and lasting impact are rare and anecdotal. Aggressive programs of recognized best practices have even experienced declines in vaccination rates over 1 to 2 years.95

Unfortunately, randomized controlled trials61,89,120,121 are all but absent, and few studies have provided a theoretical framework to guide replication and build our understanding of what makes best practices work. Most surveys, including preintervention–postintervention studies, have been cross-sectional, relying on convenience samples and self-reported recall. Programs that have achieved substantial improvements (i.e., >10% increases in coverage, but typically with rates still <50–70%) have invariably implemented multipronged efforts, making it difficult to tease out the components that contributed more (or less) to outcomes. Moreover, similar programs have yielded different effects. Progress sometimes takes several years, but even multiyear intensive efforts also demonstrate limited success. Rarely is more than 70% coverage achieved without a mandate, even with programs that bundle multiple documented best practices.89,118

Hence, the strategy needed to consistently achieve the immunization rates of 90% and higher needed for herd immunity is to require vaccination as a condition of healthcare employment. Like APHA,7 some professional associations have proposed such requirements: the Infectious Diseases Society of America (IDSA), American College of Physicians (ACP), and the National Patient Safety Foundation.65,79,122,123 These positions recognize that education is not enough to change unfounded beliefs or misconceptions108,124,125 and that knowledge is not enough to ensure healthful behavior or consistent adherence to good infection control practice.126 The American College of Occupational and Environmental Medicine (ACOEM) took the position that “education and adherence to infection control practices should be mandatory” in 2006 but questioned whether evidence regarding the benefit of healthcare worker vaccination to patient safety was then currently adequate to override workers’ autonomy to refuse.127 Since then, more than 100 institutions across at least 30 states, Puerto Rico, and the District of Columbia—small and large, public and voluntary—have successfully implemented mandates.79 Reports from these institutions and multifacility systems indicate that mandates are a highly effective intervention, resulting in the highest reported rates for any intervention designed to improve coverage.79,118,124–130 As more employers establish and implement requirements, reports demonstrate their effectiveness with little, if any, negative impacts. A CDC-sponsored RAND Corporation study found that when healthcare employers required staff to be vaccinated against seasonal flu, the vaccination rates were twice as high as when employers recommended vaccination but did not require it.97

Facilities that instead allow “informed declination” after education report mixed results, ranging from improved rates to no effect.84,93,94,119,128,131–136 Employee response has included nonparticipation, perceptions of coercion, and opposition to being required to sign a form and specify a reason for not getting vaccinated. A review of 22 hospitals’ use of such refusal statements found that vaccination rates improved only modestly.135 ACOEM thus discouraged declination statements as a poor use of resources that can distract from education and the mission of improving vaccination coverage.127 Indeed, an IDSA survey of 99 facilities across the country found that requiring declinations was less relevant to vaccine uptake than other program elements (such as providing free vaccine, targeting education, and ensuring program resources).84,93 After California mandated signed declinations, significantly more staff at Southern California Kaiser Permanente’s 12 hospitals signed declinations than with the previous system that allowed those “not wishing vaccination to [voluntarily] state their reasons,” but more than 35% of the targeted health workers still remained unvaccinated.134 By contrast, when BJC Healthcare in Missouri implemented a requirement for staff at its 13 hospitals to be vaccinated, fewer sought medical or religious exemptions than in previous years and fewer than 2% remained unvaccinated.128

Declination must be regarded as a last resort, not as an alternative. It is essential that getting vaccinated is made easier and more convenient for workers than opting out and, likewise, the procedures for obtaining an exemption must be just as rigorous as those involved in getting the vaccine.81,94,135–138 Given that unvaccinated clusters within a work unit, facility, or other group setting may compromise herd immunity, allowing broad philosophical or personal belief exemptions can threaten the effectiveness of vaccination programs.139–141 Some ethicists maintain that the bioethical principle of justice precludes refusing vaccination for personal ideological reasons, including conscientious objections.142

Declining vaccination must not be a simple, perfunctory process of completing a checklist or signing a form acknowledging risk and the right to reconsider and get immunized later. Hence, some institutions require an individual’s personal attestation (not a check on a form) of religious belief about vaccination, whereas others require documentation from clergy; with both of these approaches, additional verification that vaccine history demonstrates consistent application of the belief is also required by some. Documentation of a medical contraindication should be required, with review by the director of employee health services, not simply received and filed by employee health services administrative or clerical staff. Temporary exemption should be given, subject to reevaluation, when indicated by the nature of the medical condition. Although medical information is confidential, hospital administrators and unit supervisors must be systematically updated on staff vaccination status throughout the season.

Patient Safety Concerns in Healthcare Settings

The patient safety issue has been highlighted by the Joint Commission, the Society of Healthcare Epidemiology of America, IDSA, ACP, the Association of Professionals in Infection Control and Epidemiology, ACOEM, the National Patient Safety Foundation, the National Foundation for Infectious Diseases, the Immunization Action Coalition, the Society of Healthcare Epidemiologists of America, and the Hospital Infection Control Practices Advisory Committee of the CDC.78,79,88–90,118,122,127,143–145 The consensus among these national agencies and organizations is that influenza vaccination of health workers is crucial. Unvaccinated workers can introduce infection or propagate an outbreak in any facility or congregate community setting. Barrier precautions must be considered for unvaccinated workers (regardless of the reason for not being immunized) when they are within a specified proximity of susceptible patients.78,79,85,123

Hospitalized patients who develop nosocomial influenza have a high mortality rate.15,17,52,68,94,146 Patients can be at risk of infection when exposed to infected health workers—both those who have no symptoms and are unwitting vectors and those who work while feeling ill, even with ILI symptoms during flu season. The latter presenteeism is a well-documented problem.85,101,147 Ensuring that symptomatic staff remain off work until recovered is important—indeed essential—but because the silent incubation period allows them to infect others, it is even more important to prevent their infection. Indeed, unvaccinated healthcare workers have been implicated as sources of influenza infections in deadly outbreaks among adults and children in both acute and long-term care settings.44,52,61,146,148

Unfortunately, neither nosocomial influenza nor staff vaccination status has been routinely tracked at hospitals, but available data nevertheless demonstrate a link between staff vaccination and nosocomial infection.117,149–152 A national survey of 50 university-affiliated hospitals found 62% monitored healthcare-associated influenza, documenting a range of 0 to 5 cases per 10,000 inpatient days.119 A tertiary medical center that tracked hospital-acquired influenza for more than a decade found a strong association with the vaccination rate of healthcare workers: The nosocomial infection rate was totally eliminated when the staff vaccination rate rose 63% above its baseline rate.131 Staff vaccination rate in the emergency department setting has been associated with lower absenteeism; with higher vaccination coverage, staff take fewer sick leave days per person, and fewer staff take leave with ILI.86

Immunizing staff even adds complementary protection to the most vulnerable and those with weaker immune responses to vaccination.21,31,42,43,50,70–76,131,153 Epidemiology shows that staff immunization is necessary to control outbreaks in nursing homes, even when there are high immunization rates of residents.31,70–76,131,153,142 A RAND Corporation study of 301 nursing homes found that, regardless of facility size, only the immunization of both staff and residents reduced the rate of ILI cluster outbreaks.131 Even when 60% of patients have been vaccinated, vaccinating staff enhances mortality reduction.130 These findings are especially relevant when the season’s vaccine is not well matched to the most common virus strain; that is, even higher vaccine uptake is then needed to achieve group protection (herd immunity).

Influenza Vaccination as a Condition of Healthcare Employment Is Essential to the Health Sector’s Capacity for and Commitment to Worker, Patient, and Community Safety

A Joint Commission infection control standard requires accredited hospitals, long-term care facilities, and home health providers to evaluate staff vaccination coverage each year and take steps to increase it.88,89 Some debate, nevertheless, persists about how great a benefit will be gained from universal vaccination of workers in healthcare facilities and whether the benefit will outweigh the cost and effort involved. However, the suggestion is not that available evidence favors nonmandatory approaches. Rather, authors point to the relatively limited data documenting the influence of health workers’ vaccination status on morbidity and mortality in nursing homes, the lack of surveillance for nosocomial influenza, and the limited examination of the relative impact of different approaches to improving vaccination coverage.31,127,132,144–152,154 To be sure, the almost nonexistent baseline data and the lack of monitoring at and across most facilities must be recognized. Healthcare employers do not routinely assess, document, or track vaccination status (of staff or clients), nor is surveillance of nosocomial influenza or worker ILI routine. Moreover, the impact of improved coverage can be difficult to measure. For example, with high rates of presenteeism, lower absenteeism may not always follow improved worker vaccination rates (although improved absenteeism has indeed been reported28,29,86).

Nor can inferences about workers’ “refusing” vaccination be made from extant data about vaccination status. Action must therefore be guided by the precautionary principle,4,6 especially given the current ACIP/CDC recommendation for universal adult vaccination against influenza.87 Not all public health policy can have an extensive evidence base.154,155 While we seek quantifiable evidence on which to base decisions, uncertainty is endemic with respect to the impact of population-focused prevention interventions on reducing health inequalities.156 Indeed, evaluation of vaccine effectiveness (as opposed to efficacy) is inevitably retrospective157 and must likewise be so for immunization programs and policies. Individual-level vaccination data are important, but ecological designs are needed to evaluate real-world effectiveness of population-level interventions’ impact on herd immunity, transmission, and illness.

Proponents of mandates maintain that much better vaccination coverage can be achieved for the same expenditure of effort and resources used in aggressive voluntary programs that allow workers to remain unvaccinated.63,83,85,129,146,158,159 Available data support this view. Making protective measures enforceable is a mechanism to ensure compliance that does not exist with voluntary guidelines.160 Strict adherence to infection control is routinely expected as both a standard of care and a condition of employment. Compliance is considered preventive behavior, and noncompliance is a risk behavior. Poor compliance with vaccination standards or other basic infection control recommendations (e.g., hand hygiene and sharps and barrier precautions) may have its roots in failure to learn basic, essential practices while a student and then confusion about when and how to use them persists, especially when not unequivocally maintained as a workplace expectation and not consistently and universally modeled by more senior coworkers, even those recognized for their clinical expertise.108,161 Researchers have found that perception of supervisory expectations and anticipation of reprimand for nonadherence were the strongest predictors of adherence for all types and levels of staff surveyed in critical care units, more relevant than knowing recommendations for influenza PPE and believing in their efficacy.162

Opponents’ primary concern is the loss of worker autonomy. Some raise a concern that making immunization against influenza a condition of employment could alienate or polarize workers, damage staff morale, and produce a counterproductive backlash.132 Reports of implemented mandates do not suggest this occurs even when there is some initial opposition or continuing resistance. Nevertheless, despite the near universal success of employer mandates, the sanction of job loss for refusal to comply is real and has occurred, albeit rarely (e.g., 2 of 6,000 person staff).81,128,163–165

Conditions of employment are not inherently coercive.167 Requirements can be introduced without disrespecting employees. It should not be assumed that in the context of a mandate, whether an institutional initiative or external regulatory requirement, workers will be forced to take vaccine involuntarily but rather that with a changed circumstance/condition of employment (i.e., the addition of a mandated annual deadline for universal coverage), those that would not otherwise avail themselves of the opportunity will access vaccination. Many workers do not get immunized merely because they forget or procrastinate103,168,169 and need the final nudge that a mandate and potential sanction provide.

Rather than seeing mandated protection negatively, it can be regarded as evidence of caring about workers’ health, reflecting that the essential core of health care is people caring for people.170,171 In turn, getting vaccinated is a social behavior that reflects personal and professional subjective norms and perceptions of both peers’ opinions and family approval and need for protection.110,113,124,170–176 The PRECEDE model suggests that mandates serve as predisposing or reinforcing factors, while making access convenient enables the individual to take action.103 Researchers repeatedly find that even unvaccinated healthcare workers favor making vaccination mandatory85,101,102,110,176,177—as many as almost three-fourths of unvaccinated respondents in some surveys. In other words, while recognizing its important benefit, they depend on the system to make sure they receive it.

Unions maintain that, as conditions of employment, vaccination requirements should be negotiated at the collective bargaining table.56,90,91,170 They have called for employers to provide annual education and to make vaccine available free and around the clock (i.e., at worksites and while workers are on duty) without requiring staff to participate. Some also oppose requirements to specify a reason for declining or to sign a declination.

Civil libertarians do not object to hospitals requiring employee vaccination, but they do oppose government-initiated mandates as excessive government encroachment on individuals. The proposal of mandates raises conflict between public health imperatives and personal autonomy, and debates over vaccine mandates can elicit intense emotions.171,178 Americans, more so than other cultures, sharply distinguish between private and public realms and applaud, if not revere, individualism. However, communitarian considerations also are a strong part of our cultural heritage, and government regulation can intrude and override privacy and autonomy to protect community health and well-being.

The US Supreme Court affirmed the constitutionality of state laws restraining individual liberty to protect the public’s health more than a century ago. Debate nevertheless persists regarding the limits of government authority to restrict personal liberty in the interest of the public’s health. In a New England Journal of Medicine review of arguments against immunization mandates for health workers, Stewart and Rosenbaum concluded that constitutional challenges against the mandates are unlikely to succeed: “The judiciary has consistently affirmed that an individual’s right to refuse immunization is outweighed by the community-wide protection conferred by immunization”165 even in the absence of a public health emergency or “clear and present danger” to public safety.179p2017 There is also no constitutional requirement for states to offer nonmedical exemptions to immunization requirements, such as religious exemptions.165,179

In addition, the federal government could attach conditions of staff immunization on facilities’ participation in Medicare, Medicaid, or other federally funded programs, such as education or research support. Although employer-initiated requirements sometimes face legal challenges that focus on the technicalities of a specific labor contract or the employer’s obligation to negotiate employment conditions, the US Supreme Court has ruled that states may promulgate regulations that restrict contracts and affect employer–employee relations.166,177 Opponents have also contested180–182 a state health department’s jurisdictional authority to mandate immunization against influenza,183 despite its explicit statutory authority for the administration of facilities, home health agencies, and hospice organizations. This case was not adjudicated, but when a similar mandate for rubella vaccination was challenged, the state’s court found it was reasonable. “The Commissioner of Health [is charged] with the responsibility of making hospitals safe places to get well. These regulations are tailored to accomplish that end. The question respecting these regulations is not why now, but what took so long?”184p19 Thus, given the evidence of both influenza transmission from workers to patients and the immunization status of the healthcare workforce, requirements for health workers to be vaccinated likely rest on a viable legal platform.165

Antivaccine activists target both healthcare personnel and policymakers with misinformation about vaccine safety and efficacy, including pseudoscientific arguments that counter public health goals.185–193 They reject epidemiological data about population-level risk as well as the premise that vaccination benefits accrue to both society and the individua1.193 Modern technology makes the dissemination of myths, misinformation, and falsehoods easy. As vaccine safety concerns, even disproven ones, have become increasingly prominent, some people have come to view the negligible risks associated with vaccination to be more salient than disease threats.157,194 Misunderstanding about the seriousness of influenza is indeed widespread. It has been suggested that there are more myths related to seasonal influenza vaccine than any other.88 Given that many less serious conditions are often referred to as “flu,” its high morbidity is frequently questioned. Common myths about the vaccine’s safety are that it is untested, that it contains a dangerous adjuvant or toxic preservative, and that it can cause influenza. Persistent misunderstanding about occurrences of Guillian-Barré syndrome associated with the 1976 swine flu vaccine adds to confusion.195–200

Health workers (including physicians and nurses), are not immune to misconceptions about vaccines in general or to influenza vaccine myths.31,66,107,125 Along with “not getting around to it,” unvaccinated workers offer unfounded fears about the vaccine’s safety and misconceptions about both influenza and influenza vaccine as their reasons for not getting vaccinated, including a belief that the vaccine can cause the disease or the assertion that “I never get the flu.”103,107 Many do not recognize the risk that they themselves might pose to family and friends as well as patients even when they have no symptoms.66,107,201 Moreover, even staff in high-risk settings, such as critical care units, report poor adherence (<50%)—by both coworkers and themselves—to recommended use of influenza PPE even with patients on airborne or droplet precautions.162

Community/General Population—Beyond Hospital Walls

Health work settings include not only acute and chronic care facilities (e.g., hospitals, nursing homes, skilled nursing facilities, long-term residential facilities, rehabilitation care centers, residential substance abuse treatment programs) but also outpatient facilities (e.g., medical and dental offices, clinics and community health centers, urgent care centers) emergency services, and community-based residential settings ranging from group homes to assisted living facilities. Of no less concern is the safety of workers in home care, school health services, shelters for the homeless, mental health centers, senior centers, day care centers for adults or children, and the like, along with the safety of the people served in these settings. Nursing home assistants have been called the forgotten workers, but home care workers are the truly invisible, whether caring for children or elders, and are least likely to have employer-paid health insurance or other healthcare benefits, such as vaccination. Often providing the only support for the community’s frail, disabled, or homebound, they have an essential role in the health sector. Unlike in hospitals, clinics, and medical offices, the home care worker typically has less control over environmental infection control than workers in other settings, usually works alone and without supervision or collegial assistance, and may have to improvise when supplies run out. Likewise, the “medical rooms” or “nurse’s offices” in schools usually have not been designed to facilitate respiratory infection control.

Ethical Rationale for a Mandatory Approach

Public health’s societal reach has strong ethical foundations. Vaccination mandates represent an important area of focus for ethics, equity, and public health practice, acting as an equalizer for those who fall through the cracks.70,202,203 With few exceptions,204–206 ethical reviews that weigh the pros and cons of requiring healthcare worker influenza vaccination conclude with support for the mandatory approach.82,164,207–213 For example, Anikeeva and colleagues noted in the American Journal of Public Health that “It is unlikely that purely voluntary programs [though preferable] will achieve vaccination rates that are sufficient to meet the ethical obligations of beneficence and nonmaleficence . . .. [E]vidence shows that the most successful option for increasing vaccination rates is to make annual immunization of health care workers mandatory” with sanctions for refusal.214p28 Statdtlander responded, further asserting that from the individual patient and public/societal perspectives, the unvaccinated healthcare worker pursues his or her own interest and misses the opportunity to demonstrate personal and professional integrity.80 Matthew Wynia, director of the American Medical Association Institute for Bioethics, likewise asserted that mandates are “sorely needed” and that there should be “significant barriers to opting out.”81

The ACP call for making healthcare worker influenza vaccination mandatory emphasizes the ethical underpinning: “Vaccinating healthcare workers against influenza represents a duty of care, and a standard of quality care, so it should be reasonable that this duty should supersede healthcare worker personal preference.”122p2

Public health ethics discourse addresses the principles of beneficence, nonmaleficence, and justice, applying a population-level interpretation of the latter and adding the principles of interdependence and moral equality, which medical ethics does not address.81,156,159,215–220 Moral equality means that what matters to everyone is intrinsically superior to an individual’s claim of what matters. Public health is not exceptional with regard to this principle; it is a core social value, explicit in the United Nations Universal Declaration of Human Rights.156 How society demonstrates these values reflects its approach to the vulnerable.219 To ensure equity protection, Buchanan argued that justice must have priority over autonomy.220 Because public health issues focus on communities and their well-being, the crucial question is whether an intervention program achieves a stated public health goal and is implemented fairly, balancing the known and potential benefits and burdens.220 As Burgio and Marseglia reminded us, “It is too easily forgotten that living in society implies a contract of solidarity.”142pS55 Burris echoed this view, saying “The individual choice heuristic powerfully impedes public health work. . . . The task for public health advocates is [to change attitudes] . . . to get past the notion that individualism is an immutable [American] trait . . . that must be accepted” and seek alternative ways of thinking that will “make public health viable.”218p1609

For organizations with a healthcare mission, a population focus on health (i.e., public health) is an aspect of organizational ethics.221 Achieving near universal influenza vaccination rates is thus part of the moral grounding of healthcare organizations, integral to a contract of solidarity with their communities, not merely an aspirational idea. The community at large may regard health workers’ actions and their employers’ requirements as an indicator of whether to place importance on particular preventive health guidance. Indeed, healthcare providers are cited as the most frequent source of information about vaccines and vaccination, even by unvaccinated people and the parents of unvaccinated children.222 Thus, it is posited that health workers have a responsibility to the public—to patients and society at large—to demonstrate confidence in and adherence to scientific standards.222 This concern takes on particular resonance in the context of the current ACIP/CDC recommendation for universal immunization against influenza of everyone older than 6 months.223

To be ethical organizations, healthcare institutions must recognize a derivative obligation to create policies based on ethical principles that promote behavior consistent with patient safety and public health goals.221 Fearing employee resistance and pushback should not override such goals. Rather, because responsibility for improving coverage is shared by both employers and employees, there must be engagement in continuing dialogue beyond education—across all levels and units of the organization, with sincere efforts to recognize, understand, and respect the wide range of beliefs and concerns that can exist regardless of scientific evidence. Different social groups may view public health interventions from different perspectives. Collaborative planning agencywide with all levels of staff from diverse work units, including unions and other stakeholders as legitimate partners, is essential to building trust. Agreement on the ultimate goal of universal coverage can be a mutual starting point: promoting health and safety and preventing illness, suffering, and death. The success of any effort relies on building and preserving mutual respect and trust and recognizing that responsibility for improving coverage is shared by both employer and employee. In this endeavor, the interests of both workers and patients are aligned, and workers can feel that everything is being done to protect them.201

Stepwise implementation and initial soft enforcement may be effective. Some employers have first boosted coverage by initially coupling recommendations for vaccination with education and promotion campaigns and then advancing in a subsequent season to requiring signed declinations with individual employee health counseling, perhaps along with supervisory feedback before moving to fully implement a vaccination requirement that precludes declining for other than religious grounds.65,118,128,135 Leapfrogging directly to a fully mandatory policy can be a more practical and cost-effective approach for others and may be more efficient when a large proportion of the community or an institution’s staff is susceptible.

Conclusion

Requirements for influenza vaccination are congruent with existing standards of prevention practice for other conditions. Requiring vaccination for workers in clinical settings is a long-time, widely used standard practice when healthcare workers can be vectors of infection, particularly airborne pathogens. For example, requirements for measles, varicella, and rubella immunization are virtually unquestioned and have been effective in controlling outbreaks and reducing nosocomial transmission. Some states already mandate influenza vaccination for workers in long-term care facilities, and several have requirements for acute care facilities.59,224,225 More consistent enforcement is needed, along with adequate funding for monitoring and evaluation.

Vaccination requirements must be part of comprehensive worker and patient safety programs, which start with promoting an organizational culture of safety that involves all levels of staff in planning, implementation, and evaluation. A culture of safety permeates the organization from the top and colors every decision within it.226 It reflects a commitment that all are entitled to the highest quality protection.201 Providers are accountable to the service-seeking public to ensure optimal safety conditions. There must be broad stakeholder engagement across the health sector, including public health and related regulatory agencies, to prevent the spread of infection and reducing harm from complications. Recognizing employee vaccination as an important safety measure, all steps needed to maximize coverage must be taken.89

The rationale for initiating requirements is not to have an easy substitute for well-run programs but rather a means to enhance them and ensure goal achievement. Mandates provide the blueprint for accountability; they also require cooperation. They involve an intensive education effort, logistical planning, and outreach to make vaccine administration conveniently accessible. As with other initiatives, the implementation of mandates requires tailoring to specific settings, individual institutions, and their employees. A one-size-fits-all approach cannot suit the needs of the varied population of health workers and diverse institutional cultures. Vaccine supply may sometimes require a flexible deadline for vaccine administration. Like any policy or program, vaccination programs, whether they involve mandates or not, should be subject to review and modification as new data accumulate.

Continuing evaluation to determine the effectiveness of institutional mandates and external regulations or legislation, which should address appropriate data collection for evaluative monitoring—with standardized, uniform definitions for tracking criteria—capable of producing the scientific evidence needed for risk assessment and capable of assigning responsibility is essential. Annual, discriminate monitoring of mandatory and nonmandatory program implementation and outcomes is needed to track costs and workers’ participation in education activities, vaccination status, medical contraindications, medical waivers, reasons for requests to decline vaccination, illness and absenteeism during influenza season, and responses to and satisfaction with vaccination program components. Evaluation studies using large administrative databases must, therefore, be key components of public policy for immunization. Nosocomial influenza monitoring must likewise be part of routine institutional surveillance.

Requiring vaccination of health workers is not a panacea for influenza control and should not divert attention from other important infection control measures.

Mandates rest on the premise that a sufficiently vaccinated workforce is a critical component of maintaining and promoting the public’s health. Whereas health workers may choose to pursue other individual health behaviors, their vaccination choices, and the potential result of those choices, affect all others with whom they come in contact.

Therefore, the American Public Health Association—

Urges providers, employers, and other organizations to implement comprehensive infection control programs that include vaccination requirements along with vaccination training and education, respiratory protection, standard respiratory precautions, and housekeeping routines in keeping with infection control standards.

Emphasizes that vaccination of health workers is important not only for patient safety but also for their own protection and calls for strengthening both the health sector’s commitment to safe working environments and its capacity to achieve national goals for protecting the health workforce from influenza through education and convenient access to employer-provided vaccination.

Strongly recommends that institutions that train health professionals, deliver health care, or provide laboratory or other medical support services require immunizations for personnel at risk for contracting or transmitting vaccine-preventable illnesses.

Encourages institutional, employer, and public health policy to require influenza vaccination of all health workers as a precondition of employment and thereafter on an annual basis, unless a medical contraindication recognized in national guidelines is documented in the worker’s health record. An educational component should be created for health workers to learn about vaccine safety science.

Urges providers of health and related social services, professional associations, and unions to promote greater influenza vaccination uptake by healthcare workers as an essential component of worker safety programs.

Encourages other organizations and associations involved in promoting public health and those representing health workers to endorse positions that promote annual influenza vaccination of health workers, including affirmative support for requirements such as public position statements, public service ads, testimony in public and government forums, and friend-of-court briefs when legal challenges to them are raised.

Recommends that schools and programs of public health, medicine, nursing, dentistry, and other health professions and occupations promote awareness of the science underlying the safety and efficacy of influenza vaccination and the ethical responsibility of health workers to put the interests of public health and safety ahead of personal preference and convenience.

Advises that requirements should not place additional burdens on workers and emphasizes that employers of health personnel have the responsibility to offer vaccine and facilitate vaccine administration at worksites or other convenient locations and times. Employer responsibility for administering vaccine to staff should not be deferred to local health departments.

Advocates for assurance of compensation to health workers and their families if serious vaccine-associated adverse events arise, with explicit inclusion in the federal vaccine injury compensation system.

Urges strong surveillance of both occupational and nosocomial influenza rates and related complications, as well as continuing evaluation of health worker vaccination programs, including required efforts.

Calls on the National Institute for Occupational Safety and Health and Occupational Safety and Health Administration to promote and facilitate acquiring the data needed to track site-specific health worker exposures and outcomes, as well as vaccination coverage and its impact.

Supports continued prioritization of health worker and first responder vaccination in emergency preparedness plans as well as seasonal epidemics.

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National Foundation for Infectious Diseases. Immunizing Healthcare Personnel Against Influenza: A Report on Best Practices. Bethesda, Md: National Foundation for Infectious Diseases; 2008. Available at: www.nfid.org/HCWtoolkit/BestPracticesToolkitDocument.pdf. Accessed November 28, 2009.

American College of Physicians. ACP Policy on influenza vaccination of health care workers. www.acponline.org/clinical_information/resources/adult_immunization/flu_policy_hcw.pdf. Accessed November 24, 2009.

American College of Occupational and Environmental Medicine. Position statement: seasonal influenza prevention in health care workers. Elk Grove Village, IL: American College of Occupational and Environmental Medicine; 2006. Available at: www.acoem.org/guidelines.aspx?id=5362. Accessed December 2, 2010.

Health Protection Agency. Influenza A outbreak in a community hospital in southeast Wales where few healthcare workers had received immunization, February 2005. CDR Weekly. 2005;15(8). Available at: www.hpa.org.uk/cdr/archives/archive05/News/

Caplan AL. Do your duty and roll up your sleeves: the ethics of vaccine mandates. Paper presented at: Cutting Edge Issues in Contemporary Bioethics; April 22, 2010; State University of New York Downstate Medical Center, Brooklyn, NY.

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